OBJECTIVE:

• The purpose of this procedure is to define a systematic, risk-based process for initiating, evaluating, approving, implementing, verifying and closing changes that may impact product quality, patient safety, data integrity, regulatory compliance or business continuity.

 SCOPE:

• This procedure applies to all GMP-relevant changes within the company, including but not limited to facilities and utilities; equipment and instruments; production and packaging processes; materials, specifications and suppliers; laboratory methods and systems; computerized systems and infrastructure; documents and records (SOPs, BMRs/MFRs, forms, labels and artworks); cleaning and sanitization; validation and qualification status; and quality systems and procedures.
• It covers changes initiated at all sites and functions that could affect any product, stage or market in which the company operates.

RESPONSIBILITIES:

• Initiator / Section Head:
• • • Responsible for rafting the change request with a clear description, rationale, impacted areas and preliminary classification.
    • To execute approved changes and implementation.
    • To complete all documentation related to change.

• User Department Head:
  • Ensures the change is technically sound, feasible, resourced and aligned with applicable procedures.
  • To study the impact assessment of change on respective functions and suggest / advice accordingly.
• Quality Assurance (QA) Designee:
  • To issue change control as per request and to maintain related logs.
  • Coordinates the overall CC process,
  • Classification of Change Control,
  • Verifies completion of prerequisites (Risk Evaluation, Training)
  • Monitor implementation
  • To review and identify all areas affected by change and to evaluate justification.
  • To approve and reject change requests based on risk assessment.
  • To ensure that all documentation is accurate and complete.
  • To close the change control.
  • To study the impact analysis of change.

• Designee / Head of Cross functional department, as per need:
  • To do impact analysis
  • Adhere to the task assigned according to the change control.

• Quality Assurance (QA) Head:
  • To verify completion and implementation of the approved change
  • Review and closure of change Control

• DEFINATIONS:
  • Change Control (CC): A documented and traceable process to manage proposed or realized changes that may impact GMP.
  • Risk Assessment (RA): A systematic process to identify hazards, analyze and evaluate risks using defined criteria and tools (e.g., FMEA, impact/risk matrix), and to define risk controls and residual risks.

• Minor, Major and Critical Change: A three-tier classification based on potential impact on product quality, patient safety, data integrity and compliance.
  • Minor: No impact or negligible risk; no validation or regulatory action required; local verification only. For examples,
    • Changes in vendor of non-critical excipients,
    • Change in specification status,
    • Change in the SOPs.

• Major: Potential moderate impact; verification and/or limited validation required; may require regulatory notification depending on market. For example,
  • Change in manufacturing site for final drug product to: different location.
  • Change in the RM approved vendor/ manufacturers of raw materials and primary packing components.
  • Change in the cleaning methods.
  • Change of equipment for processing or packing.
• Critical: Potential significant impact; formal validation/qualification and regulatory variation/approval likely required; implementation is blocked until all prerequisites are satisfied. For Example,
  • Change in hardware and / or software of a computerized system linked to the manufacturing / testing or other controls.
  • Change in the utility systems such as Water system, steam supply, compressed air, HVAC.
  • Changes in formula, ingredients, their quantities.
  • Changes in the specification, testing method of RM, primary packaging component of the finished product.
  • Change in the manufacturing facility, layout, design, structure and location.
• Effectiveness Check: A planned, time-bound verification that the implemented change achieved its intended outcome without unintended adverse impact.
• Temporary Change: A change that is implemented for a defined and limited period of time, after which the process, procedure, or system will revert to its original approved state.
• Permanent Change: A change that, once implemented, is intended to remain in effect indefinitely as part of the approved process, procedure, or system.
• PROCEDURE:
  • Initiation:
• The department that requires to introduce any change shall approach to QA for Change Control Form.
• Head of initiating department shall sign the request for change and send to QA for the approval.
• Designee QA shall review the request and the rationale and if required, shall discuss with head of initiating department before signing.
• Designee QA performs a completeness check, assigns a unique CC number, registers the CC in the Change Control Log
• Designee QA shall reject incomplete requests and returns them to the Initiator with comments.
• QA shall issue the change control form by assigning it unique number as follows, CCF/XX/YY,
  • CCF – Change control form,
  • Represents the last two digits of current year
  • Represents a serial number, starting from 01, 02, on wards
  • For Example, the first change control in the year 2025 will be CCF/25/01,
• The name of initiator and department shall be mentioned.
• he date of proposal shall be mentioned.
• The change request shall be described in detail in the space provided.
• The rationale for change shall be mentioned in the space provided. Reference can be made to the supportive data as appropriate.
• Change category shall be mentioned i.e. temporary or permanent change as required.
• The initiator shall attach the documents required for approval, based on the area/nature of the change.
• Head of initiating department shall review the change with respect to its implication for previous or subsequent batches of the same product, review of all other products or system that may have been affected by the change.
• Head of initiating department shall write in brief the methodology to be adopted for implementation of change such as extensive sampling and testing, training, discussion, document updating or any other activity based on scientific rationale.

Impact Assessment and Classification of Change:

• Head of initiating department along with Designee QA shall study the impact of change on the cGMP elements such as: SOPs, approved specifications, method of analysis, Batch instructions, qualification/validation of the concerning systems, product quality.
• Head of initiating department shall also study the impact on the cGMP/ Regulatory norms, other scheduled/ planned activities/time lines, material stock etc.
• Head of initiating department shall document the details in the CC form
• A cross‑functional team conducts a documented impact assessment and shall mention the comments in the section provided, followed by approve it.
• Designee QA confirms the final classification (Minor/Major/Critical) based on the Impact Assessment outcome and establishes required approvals.
• Major and Minor Classification shall be approved by Head QA. The critical Change Control shall be approved by Higher Management, additionally.

Approval of Change Control:

• Head Quality shall evaluate the proposed change, methodology of implementation & evaluation of change and impact assessment on the product quality GMP values and regulatory conformance.
• Wherever appropriate Head Quality shall suggest risk analysis before the approval of the request. Refer SOP QA003.
• In case, the change requires the prior approval from the regulatory authorities/client, the Head Quality with the help of Regulatory affairs Designee/Manager shall obtain the same before the change can be implemented.
• On the basis of review, Head QA shall approve/reject the proposal.
• The copy of approved request shall be sent to the initiator department for their record.
• A training session shall be conducted if to understand the impact of change and how it is to be carried out.

Training and Implementation of Change:

• Before implementation, the initiator shall ensure that impacted personnel are trained on revised or new procedures and Training records shall generated.
•  Designee QA verifies that training has been completed and recorded as per Training SOP.
•  Designee QA authorizes implementation and the initiator department shall implement the change as per the methodology prepared for implementation.
• The change owner shall execute the change in accordance with approved plans and protocols, ensures contemporaneous records are generated, and coordinates document updates and controlled copy distribution and retrieval/destruction of superseded versions.
• If any, Deviation that occur during implementation are handled under the Deviation SOP.

Verification and Effectiveness Check:

• After completion of implementation, the initiating department shall study the change. Supporting data of the change under study, comparison of results with old and proposed change data, etc. shall be studied and its consistency shall be evaluated.
•  The initiator shall compile the results and the findings shall be entered in the ‘Verification and Effectiveness Change’ in the form
•  The required documents based upon the area/nature of the change shall be attached to the form.

Post Approval follow up:

• Wherever needed, Head Quality shall obtain formal approval from the client, regulatory body and/or Management before authorizing the change.
•  Head Quality may suggest for post approval action plan, if needed and designee QA shall follow up the post approval action plan with the help of concerned User Department Head.
• Once the stated activities are completed, the Head of the concerned department shall enter the remark ‘Implemented’ on the original copy of ‘Post Approval follow up’ in the form which shall be reviewed and acknowledged by Designee QA.

 Change Control Closure:

• Designee QA shall discuss the status of action plan with Head Quality and prepare a brief summary report including the actions taken and final outcome of the change control.
•  Designee QA shall close the change control form by signing and Head Quality shall approve the closure by countersigning.
• Wherever required the technical data generated during change control management shall be sent to regulatory bodies, client or Corporate Quality Management.
•  Change Control shall be closed Within 120 calendar days from initiation (Minor) and 180 calendar days (Major/Critical).
• If delayed, Justification shall give by initiator department and Approval shall need from Head QA.

 REFERENCES:

• EudraLex Volume 4, Chapter 1 (Pharmaceutical Quality System), and Chapter 4 (Documentation)
•  ICH Q10 Pharmaceutical Quality System
• ICH Q9 Quality Risk Management

RECORDS:

 REVISION HISTORY.